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EU Prohibits the Use of CMR Substances in Cosmetics, Zinc Pyrithione (ZPT) Included

EU added all CMR substances to the list of prohibited substances in Regulation (EC) No 1223/2009 as well as deleted and revised relevant substances in the lists of restricted ingredients and permitted preservatives.

With an aim to uniformly implement the prohibition of carcinogenic, mutagenic or toxic for reproduction (CMR) substances within the EU market, to ensure legal certainty in particular for economic operators and national competent authorities, and to ensure a high level of protection of human health, EU added all CMR substances to the list of prohibited substances in Regulation (EC) No 1223/2009 as well as deleted and revised relevant substances in the lists of restricted ingredients and permitted preservatives.

On Nov. 22, 2021, EU puts the amendments into force, but the actual implementation date is Mar. 1, 2022, with a grace period of more than three months. The detailed amendments are shown as follows:

1. Prohibited ingredients: 23 added, including Zinc Pyrithione (ZPT)

No.

Chemical name/INN

CAS number

EC number

1

Silicon carbide fibres (with diameter < 3 μm, length > 5 μm and aspect ratio ≥ 3:1)

409-21-2

308076-74-6

206-991-8

2

Tris(2-methoxyethoxy) vinylsilane; 6-(2-methoxyethoxy)- 6-vinyl-2,5,7,10-tetraoxa-6-silaundecane

1067-53-4

213-934-0

3

Dioctyltin dilaurate; [1]

stannane, dioctyl-, bis (coco acyloxy) derivs. [2]

3648-18-8 [1]

91648- 39-4 [2]

222-883-3 [1]

293-901-5 [2]

4

Dibenzo[def,p]chrysene; dibenzo[a,l]pyrene

191-30-0

205-886-4

5

Ipconazole (ISO); (1RS,2SR,5RS;1RS,2SR,5SR)-2-(4-chlorobenzyl)-5-isopropyl-1- (1H-1,2,4-triazol-1-ylmethyl)cyclopentanol

125225-28-7

115850-69-6

115937-89-8

-

6

Bis(2-(2-methoxyethoxy)ethyl)ether; tetraglyme

143-24-8

205-594-7

7

Paclobutrazol (ISO); (2RS,3RS)-1-(4-chlorophenyl)-4,4-dimethyl- 2-(1H-1,2,4-triazol-1- yl)pentan-3-ol

76738-62-0

-

8

2,2-bis(bromomethyl) propane-1,3-diol

3296-90-0

221-967-7

9

2-(4-tert-butylbenzyl) propionaldehyde

80-54-6

201-289-8

10

Diisooctyl phthalate

27554-26-3

248-523-5

11

2-methoxyethyl acrylate

3121-61-7

221-499-3

12

Sodium N-(hydroxymethyl)glycinate; [formaldehyde released from sodium N-(hydroxymethyl)glycinate]

if the maximum theoretical concentration of releasable formaldehyde, irrespective of the source, in the mixture as placed on the market is ≥ 0,1 % w/w

70161-44-3

274-357-8

13

Pyrithione zinc; (T-4)- bis[1-(hydroxy-.kappa.O)pyridine-2(1H)- thionato-.kappa.S]zinc

13463-41-7

236-671-3

14

Flurochloridone (ISO); 3-chloro-4-(chloromethyl)-1-[3-(trifluoromethyl)phenyl]pyrrolidin-2-one

61213-25-0

262-661-3

15

3-(difluoromethyl)-1- methyl-N-(3',4',5'-trifluorobiphenyl-2-yl) pyrazole-4-carboxamide; fluxapyroxad

907204-31-3

-

16

N-(hydroxymethyl)acrylamide; methylolacrylamide; [NMA]

924-42-5

213-103-2

17

5-fluoro-1,3-dimethyl-N-[2-(4- methylpentan-2-yl) phenyl]-1H-pyrazole- 4-carboxamide; 2'- [(RS)-1,3-dimethylbutyl]-5-fluoro-1,3-dimethylpyrazole-4-carboxanilide; penflufen

494793-67-8

-

18

Iprovalicarb (ISO); isopropyl [(2S)-3- methyl-1-{[1-(4- methylphenyl)ethyl] amino}-1-oxobutan-2- yl]carbamate

140923-17-7

-

19

Dichlorodioctylstannane

3542-36-7

222-583-2

20

Mesotrione (ISO); 2-[4-(methylsulfonyl)- 2-nitrobenzoyl]-1,3- cyclohexanedione

104206-82-8

-

21

Hymexazol (ISO); 3-hydroxy-5-methylisoxazole

10004-44-1

233-000-6

22

Imiprothrin (ISO); reaction mass of: [2,4- dioxo-(2-propyn-1-yl) imidazolidin-3-yl] methyl(1R)-cis-chrysanthemate; [2,4-dioxo-(2-propyn-1-yl) imidazolidin-3-yl] methyl(1R)-trans-chrysanthemate

72963-72-5

428-790-6

23

Bis(α,α-dimethylbenzyl) peroxide

80-43-3;

201-279-3’

2. Restricted ingredients: one revised and two deleted

Status

Chemical Name/INN

Name of Common Ingredients Glossary

CAS number

EC number

Product type, Body parts

Maximum concentration in ready for use preparation

Other

Revision

Water-soluble zinc salts with the exception of zinc 4- hydroxy-benzenesulphonate (entry 25) and zinc pyrithione (entry 101 and Annex V entry 8) (Annex II, entry X)

Zinc acetate,

zinc chloride, zinc gluconate, zinc glutamate




1 % (as zinc)


Deletion

2-(4-tert-Butylbenzyl)propionaldehyde

Butylphenyl methylpropional

80-54-6

201-289-8



The presence of the substance must be indicated in the list of ingredients referred to in Article 19(1)(g) when its concentration exceeds:

— 0.,001 % in leave-on products

— 0.,01 % in rinse-off products

Deletion

Pyrithione zinc

Zinc pyrithione

13463-41-7

236-671-3

Leave-on hair products

0.1 %

For purposes other than inhibiting the development of micro-organisms in the product. This purpose has to be apparent from the presentation of the product

3. Permitted preservatives: one deleted and one revised

Status

Chemical Name/INN

Name of Common Ingredients Glossary

CAS number

EC number

Product type, Body parts

Maximum concentration in ready for use preparation

Other

Deletion

Pyrithione zinc

Zinc pyrithione

13463-41-7

236-671-3

1) Hair products

2) Other products

1) 1.0%

2) 0.5%

Only in rinse-off products

Not to be used in oral products

Revision

Sodium hydroxymethylamino acetate

Sodium Hydroxymethylglycinate

70161-44-3

274-357-8


0.5%

Not to be used if the maximum theoretical concentration of releasable formaldehyde, irrespective of the source, if the mixture as placed on the market is ≥ 0.,1 % w/w’

Tags : IngredientsEU
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